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Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity Potential

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00705276
First received: June 25, 2008
Last updated: April 14, 2009
Last verified: April 2009
History of Changes

June 25, 2008
April 14, 2009
April 2008
May 2008   (final data collection date for primary outcome measure)
  • The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • The sensibility will be evaluated according the skin type. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00705276 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity Potential
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Delicata

To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina Delicata.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hygiene
Drug: Lactic acid (Dermacyd Femina Delicata)
Experimental: I
Intervention: Drug: Lactic acid (Dermacyd Femina Delicata)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
Not Provided
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Phototype Skin II and III;
  • Integral skin test in the region;

Exclusion Criteria:

  • Lactation or gestation;
  • Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
  • Diseases which can cause immunity decrease, such as HIV, diabetes;
  • Use of drug photosensitizer;
  • History of sensitivity or irritation for topic products;
  • Active cutaneous disease which can change the study results;
  • History or photodermatosis active;
  • Family or personal antecedent of cutaneous photoinduced neoplasias;
  • Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
  • Intense solar exposure in the study area;
  • Use of new drugs or cosmetics during the study;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00705276
LACAC_L_03983
No
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Jaderson Lima, MD Sanofi
Sanofi
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP